-
Associate Director, Process Analytics
3 weeks ago
FUJIFILM Diosynth Biotechnologies Holly Springs, United StatesThe Associate Director, Process Analytics is the system owner for this function, focusing on the drug substance manufacturing at FDBN. This role sets up and maintains · informatics systems for process analytics purposes, leads projects to create new process analytics systems, and ...
-
Associate Director, Process Analytics
3 weeks ago
FUJIFILM Corporation Holly Springs, United StatesOverview: · The Associate Director, Process Analytics is the system owner for this function, focusing on the drug substance manufacturing at FDBN. This role sets up and maintains · informatics systems for process analytics purposes, leads projects to create new process analytic ...
-
Associate Director, Process Analytics
2 weeks ago
FUJIFILM Holdings America Corporation Holly Springs, United StatesOverview · The Associate Director, Process Analytics is the system owner for this function, focusing on the drug substance manufacturing at FDBN. This role sets up and maintains · informatics systems for process analytics purposes, leads projects to create new process analytics ...
-
Associate Director, Process Analytics
2 weeks ago
FUJIFILM Holdings America Corporation Holly Springs, United StatesOverviewThe Associate Director, Process Analytics is the system owner for this function, focusing on the drug substance manufacturing at FDBN. This role sets up and maintains informatics systems for process analytics purposes, leads projects to create new process analytics system ...
-
QC Sr. Specialist 1, Instrumentation
1 week ago
FUJIFILM Diosynth Biotechnologies Holly Springs, United StatesOverview · Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO · The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and ou ...
-
QC Sr. Specialist 1, Instrumentation
1 week ago
FUJIFILM Holly Springs, United StatesFollow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO · The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, an ...
-
Data Scientist
4 weeks ago
FUJIFILM Diosynth Biotechnologies Holly Springs, United States*This role is onsite, and ideal candidate has previous experience working in the biopharma /biologics industries. · Minimum Requirements · • Bachelor's degree in Engineering, Scientific or Mathematics field with 15 years of relevant experience (e.g., Statistical Control of Manufa ...
-
Quality Control Specialist
3 weeks ago
Infotree Global Solutions Holly Springs, United StatesJob Description: · The Quality Control Specialist will be supporting the Quality Control Organization. The environment is challenging, fast-paced and ever-changing with varying degrees of process definition, but very rewarding for those who like hands-on science and want to make ...
-
Specialist Quality Control
3 weeks ago
Aequor Holly Springs, United StatesSpecialist Quality Control · Location: Holly Springs, NC · Duration: 12+ Months · **Remote for now BUT will eventually be an onsite role at Holly Springs, NC (must be in driving distance as they will eventually be required to go onsite)] · Experience with managing quality records ...
-
Safety Coordinator
1 week ago
Cenergy Holly Springs, United StatesUnder the direction of the Director of Operations, the Safety Coordinator is responsible for establishing and maintaining a collaborative safety culture that adheres to all regulatory standards and beyond. The position is also tasked with developing safety policies, procedures an ...
-
Sr. BI and Analytics Specialist
2 weeks ago
FUJIFILM Corporation Holly Springs, United StatesOverview · Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO · The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and ou ...
-
MCS Associate Quality Control
2 weeks ago
Aditi Consulting Holly Springs, United StatesSummary: · Under general supervision, this position will perform routine procedures and testing in support of the lab. This position will be responsible for one or more of activities. · Responsibilities:Performing routine laboratory procedures · Routine analytical testing · Docu ...
-
Estimating Senior Manager, Project Controls
1 week ago
Amgen Inc. Holly Springs, United StatesJOB ID: R LOCATION: US - North Carolina - Holly Springs WORK LOCATION TYPE: On Site DATE POSTED: Mar. 25, 2024 CATEGORY: Operations SALARY RANGE: 145,730.00 USD - 172,225.00 USD · HOW MIGHT YOU DEFY IMAGINATION? · If you feel like you're part of something bigger, it's because you ...
-
Senior Audit Analyst
3 weeks ago
First Citizens Bank Holly Springs, United StatesOverview: · This position serves as the technical data expert for the Internal Audit function of the Bank. Provides insight into auditing activities through complex analysis and reporting. Creates and implements enhancements to current processes and systems. Ensures that develop ...
-
QC Sr Specialist
3 weeks ago
FUJIFILM Diosynth Biotechnologies Holly Springs, United StatesOverview · Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO · The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and ou ...
-
QC Sr Specialist
3 weeks ago
FUJIFILM Holly Springs, United StatesFollow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO · The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, an ...
-
Sr. Manager, Commercial Financial Planning
2 weeks ago
CSL Holly Springs, United StatesThe Opportunity: Reporting to the Head of Finance for CSL Vifor in the US, as the Sr. Manager, Commercial FP&A, you will be a strategic partner to the Vifor US Commercial organization, overseeing the US revenue recognition process including the Gross to Net (GTN) forecast and rep ...
-
Virology Sr. Analyst I
1 day ago
FUJIFILM Corporation Holly Springs, United StatesOverview: · Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO · The work we do at FDB has never been more importantand we are looking for talented candidates to join us. We are growing our locations, our capabilities, and ...
-
Eligibility Specialist
1 week ago
UNC Health Care Holly Springs, United States**Description** · Become part of an inclusive organization with over 40,000 diverse employees, whose mission is to improve the health and well-being of the unique communities we serve. · **Summary:** · Performs technical work in obtaining Medicaid/Social Security (SSI) insurance ...
-
Senior Mechanical Engineer
1 week ago
Amgen Inc. Holly Springs, United StatesJOB ID: R LOCATION: US - North Carolina - Holly Springs ADDITIONAL · LOCATIONS: US - California - Thousand Oaks; US - Ohio - New Albany WORK LOCATION TYPE: On Site DATE POSTED: Mar. 20, 2024 CATEGORY: Engineering SALARY RANGE: 114,962.00 USD - 139,704.00 USD · HOW MIGHT YOU DEFY ...
Associate Director, Process Analytics - Holly Springs, United States - Fujifilm Diosynth Biotechnologies
Description
The Associate Director, Process Analytics is the system owner for this function, focusing on the drug substance manufacturing at FDBN. This role sets up and maintains
informatics systems for process analytics purposes, leads projects to create new process analytics systems, and expands the capabilities and functionalities.
This role also supports Process Science for the drug substance group, and ensures the systems support the business processes in place for the site.
Additionally, this role creates multivariate models and provides training in the use of process analytics systems that are currently in place
Major Accountabilities
Builds the Process Analytics team and develops the team to deploy digital solutions for real-time process monitoring and multivariate statistical process control
Supervises the Analytics team and sets the direction for individual and team goals
Leads the architecture, design, and deployment of site's process data platforms to allow machine learning models, data science applications, and other custom applications and dashboards
Leads the Process Analytics team in developing and maintaining internal data-focused webapps to support different stakeholders
Seeks to continuously optimize the data management of manufacturing processes while focusing on digital solutions
Partners with users (internal and clients) to define functional specifications and process requirements from a process data perspective,
specifically process data transmittance (sensor, control, and operation data)
Partners with users (internal and clients) for data used to support continuous manufacturing and validation, continuous improvement and regulatory commitments
Leads innovations and systems improvement initiatives in the Process Analytics space (e.g., new in-line and on-line Process Analytical Technologies
(PAT) solutions for biopharmaceutical processes with a strong focus on drug substance production process monitoring and control)
Trains relevant stakeholders on PAT tools and respective analytical approaches (e.g., multivariate models and other statistical process methods)
Establishes systems and procedures to enable proactive process monitoring, analysis, and reporting of manufacturing process data
Provides team support for investigations, root cause analysis, and optimization with data support and analysis
Functions as senior technical data leader and contact for process data, statistics, modeling, and PAT activities (e.g., automation interface between PAT analyzers and sensors and data systems)
Leads team in curating critical knowledge and developing best practices in Process Analytics space
Serves as a key stakeholder in business development and defining the future large-scale operations model, including site's digital roadmap of GxP process data
Designs and leads the development of applications and methods with model for process characterization and scale-up/out (e.g., transition analysis to monitor column integrity, e-chromatogram review)
Coaches and mentors direct reports and team members to foster professional development and growth
Enforces and ensures team adheres to company policies and procedures
Participates in the recruitment process to attract talent
Collaborates with other departments (e.g., HR, Talent Acquisition) and provides input to develop retention strategies
Addresses employee concerns and partners with HR for resolution, as needed
Evaluates team performance and address gaps appropriately
Other duties, as assigned
Knowledge, Skills and Abilities
Strong knowledge of US and international regulatory standards and ICH guidelines especially with regards to data integrity
Knowledge of PAT methodologies and implementation
Knowledge of SIMCA-Online, TIBCO Statistical, Visual Basic and Git version control
Strong attention to detail, highly organized, and solution-oriented mindset
Ability to multitask in a fast-paced, highly interactive environment
Ability to adapt communication style to differing audiences and advise others on difficult matters
Effective communication, both written and oral
Ability to effectively present information to others
Ability to provide feedback to others, including leaders
Advanced problem-solving skills
Demonstrated ability to hire and develop top technical talent to build and lead a high performing team, projects, programs while directing allocation of resources
Must be willing to travel domestic and international, 10-20%
Minimum Requirements
Bachelors degree in Engineering, Scientific or Mathematics field with 15 years of relevant experience (e.g., Statistical Control of Manufacturing Processes or Development of Data Collection/Management Systems); or
Masters degree with 12 years of relevant experience
Previous management or supervisory experience
Working-knowledge of structured query language (SQL) and experience with data science and the Python data science ecosystem (e.g., NumPy, SciPy, pandas, Scikit-learn, Jupyter Notebook)
Prior experience with data mining, management and visualization, statistical process control, and manufacturing processes
Preferred Requirements
Experience working in a Good Manufacturing Practices (GMP) environment
Experience using IT systems to support data acquisition, management, and evaluation
Prior experience collaborating and interacting with a global team
Experience with multivariate data analysis
